Ryan Shepard, Ph.D., had just finished his first year of training at NINDS, and like many other young scientists, the COVID-19 shutdown rendered him curious about scientific careers away from the bench. His first year at NINDS was not without success. He had secured a postdoctoral fellowship from the Center on Compulsive Behaviors, and he was even selected to receive the prestigious NINDS Competitive Postdoctoral Fellowship Award for research that could offer insight into treating sleep disorders.
Up until the pandemic, Dr. Shepard had only trained in rodent physiology and behavior, with limited exposure to the regulatory policies and laws surrounding human subject research. With a budding interest in the regulatory field, Dr. Shepard enrolled in extension courses to gain in-depth knowledge about the regulatory aspects of clinical trials. He was hooked. When he noticed an opportunity to work with clinicaltrials.gov at the National Library of Medicine, his previous experiences culminated into a strong application and successful interview process.
At this point, Dr. Shepard needed to decide if he would continue at the bench, with NCFA funding in hand, or venture into a new career path in clinical trial transparency and regulatory affairs. After many discussions with his mentor, Wei Lu, Ph.D., Senior Investigator in the Synapse and Neural Circuit Section, and others at NINDS, Dr. Shepard weighed the advantages and disadvantages of each choice. Ultimately, Dr. Shepard wanted to make a broad impact in science, and while balancing his personal and career goals, he made the decision to become a clinical trial results analyst—a decision, he says, he is very happy to have made.
Read on to learn more about Dr. Shepard’s career and his advice to NINDS trainees who are interested in the regulatory field.
Q: What is a week like in the life of a clinical trial results analyst?
Much of my time during the week is spent reviewing clinical trial results data (otherwise known as the study record) that has been submitted to clinicaltrials.gov. As reviewers, we read and analyze the details of the study record, which is separated into different modules: Participant Flow, Baseline Characteristics, Outcome Measures, and Adverse Events. We then evaluate the record to ensure that the data and information presented is consistent. For example, if a study reports that the baseline average body temperature for participants is 98 degrees Celsius, this would be considered a major inconsistency, as this is not physiologically possible. We would then ask the data provider to review the inconsistency and make edits to the record to address the issue.
As you can imagine, the issues can be much more challenging and complex to address. This also means that most of the day or week is spent critically thinking about a record, referencing relevant scientific literature, and commenting on records that have inconsistencies within them.
In addition to reviewing records, we often answer emails from various parties, such as clinical trial sponsors, principal investigators, statisticians, etc., to assist them with understanding how to present and enter their results. In certain cases, we also participate in teleconferences to further help guide data providers and sometimes to obtain more information on their study to better understand how their results can be reported.
Q: What do you like most about your work, and what do you find the most challenging?
One of the most exciting things about my work is that I learn something every single day. As an analyst, I am not confined to reviewing solely neuroscience related clinical trials. I also review records related to oncology, immunology, and psychology (just to name a few). Because the landscape of clinical trials is always evolving, there is always something new to analyze, whether it is a new study design or the implementation of a new assay.
I also get to play a critical role in the regulatory aspect of clinical trials reporting and transparency. This is important for all parties involved in clinical research, ranging from scientists to clinicians and even for individuals who are looking to participate in clinical trials. Considering the COVID-19 pandemic, greater emphasis has been placed across the entire scientific community (both basic and clinical sciences) to be transparent about reporting results. Getting to be on a team where this is part of my job is incredibly rewarding.
One of the most challenging aspects of being an analyst is that we are exposed to a variety of studies daily, some of which may not be clear. It is then up to us to dissect the record utilizing information the data provider has provided, such as the Study Protocol and/or Statistical Analysis Plan, as well as reading the relevant literature. We have an amazing, collaborative team that works together whenever there is difficulty understanding a record.
Q: What skills, abilities, and personal attributes are essential to success in your position, and how did you grow those skills as an NINDS trainee?
Critical thinking, statistical reasoning, and communication are critical skills needed for my position. The process of going through the fellowship application process, as well as publishing my research, provided an opportunity to critically assess my projects and allowed me to sharpen my communication skills. Through my research, I also developed a good understanding of statistics—in particular, the rationale for why different statistical tests are used for specific sets of data.
During lab meetings, we had a chance to apply our critical thinking skills while providing suggestions for each other’s work based on our understanding of the research question and prior knowledge. In addition, my role as an independent reviewer for journals gave me additional insight and experience in evaluating scientific studies.
Q: What advice would you give to current or prospective NINDS trainees who are interested in a similar career field?
There is no such thing as “leaving science” – a term that should be retired. Rather, there are a wide variety of opportunities to do various types of science that are beyond the bench. Don’t hesitate to reach out to professionals involved in the broad field of clinical trials research. Many professionals will be open to answering questions about their career experience and could potentially even be a referral by knowing what your career aspirations are or could be! There are so many different positions and opportunities that are available to Ph.D. holders, ranging from policy to data science.
Make sure your LinkedIn is up to date, as this can help recruiters identify you, as well as help you make connections with other professionals. LinkedIn has become an important part of the job search process. This is how I found the job posting for my current position!
I also think something that helped me was having a fundamental understanding of how clinical trials are conducted and the basic regulatory principles that sponsors must follow. This can be achieved through self-study or taking courses. In the end, be passionate about what you want to achieve, both professionally as well as personally, and don’t be afraid to take a leap and try something different.
Contributed by Shana R. Spindler, Ph.D., freelance science writer and former NIH postdoctoral fellow.